EXCOR Pediatric Ventricular Assist Device System - Blood Pumps and EXCOR System - Blood Pump PU Valves (2018-05-18)

Starting date:

May 18, 2018

Posting date:

June 22, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67070

• 
  Reason
• 
  Affected products

Affected products

• A. EXCOR Pediatric Ventricular Assist Device System blood pumps
• B. EXCOR System - Blood Pump PU Valves

Reason

Berlin Hearts has become aware of an increasing occurrence of issues with one or more of the membrane layers separating the air and blood chambers within the EXCOR Pediatric Ventricular Assist Device System Blood Pumps.

Affected products